[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598364":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":28,"responsibleParty":43,"collaborators":20,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":20,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":20,"enrollmentInfo":56,"targetDuration":20,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":68,"overallStatus":75,"whyStopped":20,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Instituto de Investigación Sanitaria Aragón","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Unified Protocol in group format","EXPERIMENTAL","Participants will receive the intervention of the Unified Protocol (UP) in a group format, consisting of 12 sessions, one per week, each lasting 1 hour. Each session includes a review of previous content, resolution of doubts, and development of new material from one of eight modules. The program covers motivation for change, goal setting, understanding the adaptive function of emotions, emotional awareness and mindfulness, cognitive flexibility, problem solving, and addressing emotion-driven behaviors. Exposure to emotional and interoceptive experiences is introduced in later sessions. Follow-up sessions at 1, 3, and 6 months review progress, reinforce learning, identify risk signals, and promote relapse prevention and long-term well-being.",[13],"Behavioral: Unified Protocol",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BEHAVIORAL","Unified Protocol","The Unified Protocol (UP) is a transdiagnostic, emotion-focused cognitive-behavioral treatment designed to address a range of emotional disorders, including anxiety, depression, and related conditions. It targets core mechanisms such as emotional avoidance, cognitive rigidity, and maladaptive emotion regulation strategies. The UP consists of structured modules focused on increasing emotional awareness, cognitive flexibility, and exposure to emotionally evocative situations. By addressing common underlying processes across disorders, the UP enhances treatment efficiency and applicability in both individual and group formats. Its flexibility makes it suitable for diverse populations and settings, including community and clinical contexts.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":26,"email":27},"Óscar Peris Baquero, Phd","CONTACT","978645386","+34","operis@unizar.es",[29],{"facility":30,"status":20,"city":31,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Universidad de Zaragoza","Teruel","44003","Spain","ES",{"type":36,"coordinates":37},"Point",[38,39],-1.10646,40.3456,{"lat":39,"lon":38},[42],{"name":23,"role":24,"phone":25,"phoneExt":26,"email":27},{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Óscar Peris Baquero","Principal Investigator","100598364","unified-protocol-in-penitentiary-facilities-100598364",false,"NCT07070531","Unified Protocol in Penitentiary Facilities","Feasibility and Clinical Utility Study of the Unified Protocol for Group Treatment of Emotional Disorders in Penitentiary Facilities","Inclusion Criteria:\n\n* At least one emotional disorder diagnosis (e.g., anxiety, depression, OCD, trauma-related, somatic, dissociative) based on the MINI interview\n* Comprehension of the intervention language (Spanish or Catalan)\n* Substance abstinence for more than 1 month\n* Voluntary participation and availability for all assessment and treatment sessions\n* Stable pharmacological treatment during the study unless medically contraindicated\n* Signed informed consent\n\nExclusion Criteria:\n\n* No emotional disorder diagnosis\n* Cognitive impairment or IQ \\\u003C70 preventing comprehension\n* Diagnosis of a mental disorder incompatible with group formats (e.g., histrionic personality disorder)\n* Suicide risk at assessment\n* Legal status involving potential release or leave that could affect adherence","ALL","18 Years",{"count":57,"type":58},25,"ESTIMATED","INTERVENTIONAL",[61],"NA","Emotional disorders (EDs), which include anxiety disorders, unipolar mood disorders, and other related conditions, exhibit a high prevalence within prison populations, significantly exceeding that of the general population. Despite the high incidence of these disorders, the resources available for their treatment in correctional facilities are limited. The shortage of both human and material resources hinders inmates' access to quality mental health care.\n\nIn this context, the Unified Protocol (UP) for the transdiagnostic treatment of emotional disorders, a transdiagnostic intervention grounded in Cognitive Behavioral Therapy, has demonstrated effectiveness in addressing a variety of psychological problems across different contexts. It has also proven to be cost-effective, particularly when delivered in a group format. Therefore, implementing the UP in group format within correctional settings could represent a viable strategy to optimize limited resources and provide accessible and effective treatment to a larger number of inmates.\n\nThe primary objective of this pilot study is to evaluate the feasibility and clinical utility of the UP for the treatment of emotional disorders in prison environments. To this end, the UP will be delivered to approximately 25 participants, organized into groups of six to eight individuals, each receiving 12 weekly sessions lasting one hour. Follow-up assessments will be conducted at one, three, and six months after the intervention.\n\nA mixed-methods approach will be employed to analyze the results, combining quantitative analyses to assess changes in emotional symptomatology and qualitative analyses to explore participant satisfaction and therapist acceptance. It is expected that participants will experience statistically significant improvements in emotional symptoms and that these improvements will be sustained over time, up to the six-month follow-up. It is also anticipated that participants will report a high level of satisfaction with the treatment. Furthermore, therapists are expected to evaluate the intervention positively and to identify potential barriers to its implementation.\n\nThe results of this pilot study will contribute to improving the feasibility and clinical utility of the UP in correctional settings, while also laying the groundwork for a future randomized controlled trial involving a larger number of facilities, participants, and therapists.",[64,65,66,67],"Depression Disorders","Anxiety","Mood Disorders","Emotional Disorder",[17,69,70,71,72,73,74],"Transdiagnostic Intervention","Incarcerated Population","Correctional Facilities","Group Therapy","Cognitive-behavioral Therapy","Emotional Disorders","NOT_YET_RECRUITING","2025-07-16",{"date":78,"type":79},"2025-07-17","ACTUAL",{"date":81,"type":58},"2025-11-01",{"date":83,"type":58},"2026-07-01",{"name":5,"class":6},1]